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Luna 1012X wireless digital flat panel detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all general-purpose diagnostic procedures. The device is not intended for mammography or dental applications.

Luna1012X Wireless Digital Flat Panel Detector (Hereinafter referred to as Luna1012X) is the kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 31.52cm×25.02cm. The sensor plate of Luna1012X is direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface. The major function of the Luna1012X is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. Both kinds of detectors are the key component of DR system, enable to complete the digitalization of the medical X-ray imaging with the DR system software. iRay SDK(include iDetector) is intended to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intend to be used directly by other users beside DR system manufacturers.

This document is a 510(k) Summary of Safety and Effectiveness for the iRay Technology Taicang Ltd. Wireless Digital Flat Panel Detector (Luna 1012X). It states that the device is substantially equivalent to a predicate device and provides information on its intended use, technological characteristics, and non-clinical testing.

However, the provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria, specifically regarding AI/algorithm performance. The document is a regulatory submission focused on proving substantial equivalence to a predicate device based primarily on hardware specifications, material safety, electrical safety, and general performance parameters relevant to an X-ray detector. It is not an AI/algorithm performance study.

Therefore, I cannot extract the detailed information requested in the prompt (acceptance criteria for an AI algorithm, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text.

The document discusses the following:

• Device Name: Wireless Digital Flat Panel Detector (Luna 1012X)
• Intended Use: Digital imaging solutions for general radiographic diagnosis of human anatomy (adult and pediatric), replacing film/screen systems. Not for mammography or dental applications.
• Predicate Device: iRay Technology Co., Ltd. Mars1013X Wireless Digital Flat Panel Detector (K220668)
• Testing: Electrical safety and EMC testing (IEC/ES 60601-1, IEC 60601-2-54, IEC 60601-1-2), Biological Evaluation (ISO 10993-1).
• Performance Parameters Mentioned (for substantial equivalence comparison, not acceptance criteria for an AI): Spatial Resolution (Min. 4.3lp/mm), Modulation Transfer Function (MTF) (Min. 0.60 at 1 lp/mm), Detective Quantum Efficiency (DQE) (Min. 0.43 at 1 lp/mm). These are standard technical specifications for an X-ray detector, not for an AI.
• Software Mentioned: iRay SDK (including iDetector) as an API interface for DR system manufacturers, not an AI software for image interpretation.

Without information about an AI or algorithm in the provided text, I cannot fulfill the request.

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